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OpenTrials
Completed

NCT Number: NCT04106895

Use of Fibryga, a Fibrinogen Concentrate in Real World: Retrospective Collection of Clinical Data

To describe the characteristics of patients treated with Fibryga®, the indications and conditions of use of Fibryga® and, for patients treated " on-demand", the short-term outcomes.

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Key information

Conditions

Bleeding Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Bordeaux Study Site, Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient with fibrinogen deficiency (congenital or acquired)
  • Having received an treatment with Fibryga® during the recollection period
  • Having been informed of the potential retrospective collection of their data by a Clinical Research Associate mandated by Octapharma® when Fibryga® has been delivered and who did not refuse.

Exclusion criteria

  • N/A

Treatment and study plan

Fibryga

Drug

Fibryga

Primary outcomes

  1. proportion of treatments given for an ongoing bleeding episodes

    Time frame: 6 months

    Estimate the proportion of treatments given for an ongoing bleeding episodes (opposed to preventative treatment administered for example before surgery or to regular prophylaxis)

Secondary outcomes

  1. On-demand Treatment Success

    Time frame: 6 months

    on-demand treatment of spontaneous or surgical bleeding episodes, success is defined as bleeding control (complete cessation of bleeding or < 20% decrease in hemoglobin).

  2. Surgical Prophylaxis Success

    Time frame: 6 months

    Surgical prophylaxis success is defined as no bleeding or oozing and control of bleeding with fibrinogen concentrate (as anticipated or requiring increased dosing or additional infusions not originally anticipated).

Sponsors and collaborators

Lead sponsor

Octapharma

Industry

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 27, 2019
Registry last updated
May 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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